Mintz Levin - Health Law & Policy Matters

Massachusetts Determination of Need Regulation Overhaul

The Massachusetts Department of Public Health (DPH) Determination of Need (DoN) Program has unveiled proposed regulations that constitute an ambitious and, perhaps, long overdue overhaul of the DoN Program regulations. Attendees…more
| Administrative Law, Health

Texas Medical Board’s Appeal Must Proceed Under Existing Jurisdiction Arguments

In another procedural defeat for the Texas Medical Board (the “Board”) over its embattled telemedicine rule, last week, a federal judge held that the Board waited too long to request certification of appeal to the Fifth Circuit…more
| Antitrust & Trade Regulation, Civil Procedure, Constitutional Law, Health, Science, Computers, & Technology

OCR to Increase Investigations of Smaller HIPAA Breaches

HHS Office for Civil Rights will cast a wider net and increase its investigations into smaller HIPAA privacy breaches starting this month. OCR announced a new initiative to increase its efforts examining breaches that affect…more
| Consumer Protection, Health, Privacy, Science, Computers, & Technology

FDA Releases Revised Guidance on Device Modification Policy

FDA released two new draft guidances on Monday, August 8 in an attempt to help device manufacturers determine when a modification triggers the obligation to file a new 510(k) under 21 C.F.R. § 807.81(a)(3). The first draft…more
| Health, Science, Computers, & Technology

Medicare to Refine and Expand its Value-Based Insurance Design Model

On August 10, 2016, the Centers for Medicare and Medicaid Services (CMS) released a memorandum through its Center for Medicare and Medicaid Innovation announcing changes to the Medicare Advantage Value-Based Insurance Design…more
| Health, Insurance

Latest OCR HIPAA Settlement Provides Lessons for Covered Entities

Capping off a busy month of HIPAA settlements, on August 4, the Office for Civil Rights (“OCR”) announced a $5.55 million settlement with Advocate Health Care Network (“Advocate”), the largest fully-integrated healthcare system…more
| Consumer Protection, Health, Privacy, Science, Computers, & Technology

States’ Efforts for Drug Price Transparency Stymied by the Pharmaceutical Industry

As we previously reported, in 2015 and early 2016, bills and voter initiatives were introduced in several states that would impose drug pricing controls and transparency requirements on pharmaceutical manufacturers. Of…more
| Elections & Politics, Health, Science, Computers, & Technology

OIG Gives Green Light to Hospice Provider’s Payment to Nursing Facilities

Last week, the OIG issued a favorable opinion to a hospice provider seeking to make supplemental payments to skilled nursing facilities. Under the proposed arrangement, the hospice provider would make a supplemental payment to…more
| Health

Another Jury Acquits in One of the First Few Prosecutions of Health Care Executives Following DOJ’s Yates Memo

Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”) Yates…more
| Criminal Law, Government Contracting, Health, Science, Computers, & Technology

New Materials Help Covered Entities Comply with Nondiscrimination Rules

Last week, the Department of Health and Human Services (“HHS”) released new materials for covered entities to use to comply with Section 1557, the nondiscrimination provision of the Affordable Care Act. Section 1557 strengthens…more
| Civil Rights, Health

FDA Adjustment to Orphan Drug Review May Indicate Increased Scrutiny of Designations

In recent years, applications for orphan drug designations have flooded into FDA at a rapid pace, and this year appears to be no exception. Orphan drug applications received by FDA rose by approximately 30% over the previous…more
| Health, Science, Computers, & Technology

FDA Releases Draft Guidance on Codevelopment of Therapeutic Products and Screening Tests

On July 14, 2016, the U.S. Food and Drug Administration (the “FDA”) released draft guidance on the codevelopment of therapeutic products (such as pharmaceuticals) and companion tests that are used to determine if the therapeutic…more
| Health, Science, Computers, & Technology

FDA Deep Dive: Real Life Implications of FDA NEST Program Explored

In our Israel Connect Summer 2016 edition we summarized the FDA’s post-market surveillance data programs, including the NEST program designed to consolidate and analyze real-world device data once a device is legally…more
| Health, International Law & Trade, Science, Computers, & Technology

FDA Reorganization Takes on Cancer Moonshot and Other Initiatives

On July 11, 1969, the United States accomplished the almost unthinkable –two men walking on the moon. Conjuring images of that moon landing, President Obama moved forward the “Cancer Moonshot” program at his January 2016 State…more
| Administrative Law, Elections & Politics, Health, Science, Computers, & Technology

OCR Sends Notification Letters to Phase 2 HIPAA Auditees

On July 12, 2016, HHS’s Office for Civil Rights (OCR) distributed an e-mail discussing recent developments in Phase II of its HIPAA audit program…more
| Health, Privacy
Showing 1-15 of 917 Results
|
View per page
Page: of 62
Contact

701 Pennsylvania Avenue, N.W.
Washington, DC 20004-2608, United States

  • 202-434-7324
  • 202-434-7400

Areas of Practice
  • Administrative Law
  • Commercial Law & Contracts
  • Health
  • Litigation
  • Mergers & Acquisitions
  • Securities Law
Locations
Other U.S. Locations
  • California
  • Connecticut
  • D.C.
  • Massachusetts
  • New York
Other Countries
  • Israel
  • United Kingdom
Number of Attorneys

400+ Attorneys

This profile may constitute attorney advertising. Prior results do not guarantee a similar outcome. Any correspondence with this profile holder does not constitute a client/attorney relationship. Neither the content on this profile nor transmissions between you and the profile holder through this profile are intended to provide legal or other advice or to create an attorney-client relationship.

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×